Study Evaluating The Safety And Tolerability Of ILV-094 In Subjects With Psoriasis

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An Ascending Multiple Dose Study Of The Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, And Clinical Efficacy Of ILV-094 Administered Subcutaneously Or Intravenously To Subjects With Psoriasis

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Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Men and Women of nonchildbearing potential 18 years or older.

Physician Area and Severity Index (PASI) greater than 11.

Physician Global Assessment (PGA) greater than 3.

Exclusion Criteria:

Use of any investigational small -molecule drug within 30 days before the first dose of test article administration, and use of any investigational biologic agents within 5 half lives before study day 1, or 90 days for investigational biologics that may have a long clinical duration of effect.

Live vaccines within 3 months before test article administration or during the study.

Use of any biologic therapy within approximately 5 half-lives before test article administration. Approximate half-lives of biologic therapies approved for psoriasis are as follows: Enbrel, 5 days; Humira, 14 days; Remicade, 9 days; Amevive, 12 days; Raptiva, 6 days. It is recommended that Amevive be discontinued for at least 90 days because of its long clinical duration of action.

Topical steroids, topical vitamin A or D analog preparations, or anthralin within 2 weeks before study day 1. (Exception: topical therapies, including steroids at no higher than mild strength [class 6 or 7 topical corticosteroids], are permitted on the scalp, axillae, face, and groin, but the dose of the medication must be kept stable throughout the trial.)